Performance Qualification Protocol FOR Induction Sealing Machine (Cephalosporin Block)

MALIK LIFESCIENCES PERFORMANCE QUALIFICATION PROTOCOL No.
:
PVT. LTD. PROTOCOL ICS/PPQ/CB/001-00
HARIDWAR FOR EFFECTIVE DATE:
INDUCTION SEALING MACHINE 03/12/14
PAGE No.: 1 of 17
PERFORMANCE QUALIFICATION
PROTOCOL
FOR
INDUCTION SEALING MACHINE
(CEPHALOSPORIN BLOCK)
EQUIPMENT ID No. ML/CB/ICS-02

LOCATION CEPHALOSPORIN BLOCK (PREMIX FILLING)
DATE OF QUALIFICATION
SUPERSEDES PROTOCOL No. NIL
PROTOCOL CONTENTS
S. No. TITLE PAGE No.
FORMAT No.: CQA-004/F05-00 “Document covered under IPR of M.L.P.L. and should not be reproduced without authorization”
MALIK LIFESCIENCES PERFORMANCE QUALIFICATION PROTOCOL No.:
PAGE No.: 2 of 17
1.0
Protocol Approval 3
2.0 Objective 4
3.0 Scope 4
4.0 Responsibility 5
5.0 Equipment Details 6
6.0 System Description 6
7.0 Reason For Qualification 6
8.0 Site of Study 6
9.0 Frequency of Qualification 6

10.0
Pre-Qualification Requirement 7
11.0
Tests & Checks 8
12.0
Checklist of All Tests & Checks 9
13.0
References 10
14.0
Documents To Be Attached 10
15.0
Noncompliance 10
16.0
Deviation From Pre–Defined Specification, If Any 11
17.0
Change Control, If Any 11
18.0
Abbreviations 12
19.0
Annexure 13
PAGE No.: 3 of 17
1.0 PROTOCOL APPROVAL:
INITIATED BY:
DESIGNATION NAME SIGNATURE DATE

OFFICER / EXECUTIVE
(QUALITY ASSURANCE)
REVIEWED BY:

HEAD
(PRODUCTION)
HEAD
(QUALITY CONTROL)
HEAD
(ENGINEERING)
APPROVED BY:

HEAD
(QUALITY ASSURANCE)
AUTHORIZED BY:

Sr. GENERAL MANAGER
(QUALITY ASSURANCE)
PAGE No.: 4 of 17
2.0 OBJECTIVE:
 To provide documented evidence that the Equipment is performing as per the parameter defined
in Performance Qualification and that it gives result as per the predetermined acceptance criteria.
 To demonstrate that the system will operate reproducibly and consistently within its operating
range.
 To confirm the suitability of the Standard Operating Procedures for all routine activities
associated with the system.
3.0 SCOPE:
This Protocol is applicable for performance qualification of Induction Sealing Machine installed in Dry
Powder filling area of Cephalosporin block at Malik Lifesciences Pvt. Ltd., Haridwar. The equipment is
to be used for Sealing of bottle.
PAGE No.: 5 of 17
4.0 RESPONSIBILITY:
The Qualification team, comprising of a representative from each of the following departments, shall be
responsible for the overall compliance of this Protocol.
DEPARTMENTS RESPONSIBILITIES
 Preparation, Review, Approval and Compilation of the Performance
Qualification Protocol.
Quality Assurance  Co-ordination with Quality Control, Production and Engineering to
carryout Performance Qualification Activity.
 Monitoring of Performance Qualification.
 Review of Protocol.
Production
 To co-ordinate and support Performance Qualification Activity.
 Reviewing of qualification Protocol for correctness, completeness
and technical excellence.
Engineering
 Responsible for trouble shooting (if occurred during execution).
 Maintenance & preventive maintenance as per schedule.
 Review of Performance Qualification report.

Quality Control
 Approval of report post approval.
PAGE No.: 6 of 17
5.0 EQUIPMENT DETAILS:
Equipment Name Induction Sealing Machine

Equipment ID. ML/CB/ICS-02
Manufacturer’s Name Electronic Device
Supplier’s Name Electronic Device
Location of Installation Cephalosporin Block
6.0 SYSTEM DESCRIPTION:

The closure is supplied to the bottler with foil liner already inserted. Although there are various liners to
choose from, a typical induction liner is multi-layered. The top layer is a paper pulp that is generally
spot-glued to the cap. The next layer is wax that is used to bond a layer of aluminum foil to the pulp.
The bottom layer is a polymer film laminated to the foil. After the cap or closure is applied, the
container passes under an induction coil, which emits an oscillating electromagnetic field. As the
container passes under the induction coil (sealing head) the conductive aluminum foil liner begins to
heat. The heat melts the wax, which is absorbed into the pulp backing and releases the foil from the cap.
The polymer film also heats and flows onto the lip of the container. When cooled, the polymer creates a
bond with the container resulting in a hermetically sealed product. Neither the container nor its contents
are affected, and this all happens in a matter of seconds.
7.0 REASON FOR QUALIFICATION:
After completion of the Operational Qualification of the equipments, it is imperative to perform the
Performance Qualification. The study will establish that the parameters are followed, critical variables
are under control and the quality of the output is, as desired.
8.0 SITE OF STUDY:
Cephalosporin Block, Malik Lifesciences Pvt. Ltd, Haridwar.
9.0 FREQUENCY OF QUALIFICATION:

 Once in two year time period.
 After any major breakdown or after major modification.
 After Change of Location.
PAGE No.: 7 of 17
10.0 PRE-QUALIFICATION REQUIREMENTS:

10.1 TRAINING: Training shall be given to the concerned persons and details recorded into the annexure-I.
10.2 SYSTEM PRE-REQUISITES:
Verify that the DQ / IQ / OQ of the Induction Sealing machine have been executed and approved.
Verify that the SOP for Operating, Cleaning and Preventive Maintenance of the Induction Sealing
Machine has been prepared.
COMPLETED CHECKED BY VERIFIED BY
DESCRIPTION OF
S. NO. (YES / NO) ENGINEERING QA
PRE-REQUISITE
SIGN / DATE SIGN / DATE
Verify that the DQ / IQ / OQ of

the induction sealing machine has
been executed and approved.
DQ Protocol Document No.:
1.
ICS/PDQ/CB/001-00
IQ Protocol Document No.:
2.
ICS/PIQ/CB/001-00
OQ Protocol Document No.:
3.
ICS/POQ/CB/001-00
4. SOP of “Operation and Cleaning
of Induction Sealing Machine”
SOP No.: LPJ/015-00
11.0 TESTS & CHECKS:
PAGE No.: 8 of 17
11.1 CONVEYER SPEED TEST:
Objective:
The objective of the test to determine the effect of Conveyer speed on product quality.
Scope:
The Scope of this test limited to the Dry Powder Filling Area of Cephalosporin Block at Malik
Lifesciences Pvt. Ltd.
Procedure:
 Switch on the conveyer Belt Machine.
 Operate the machine as per respective SOP.
 Set the Minimum, Standard and Maximum speed of Conveyer Belt.
 Put the Bottles on the conveyer belt.
 Check the effect of speed on bottle.
 The result record into the annexure-I.
Acceptance criteria: The conveyer belt should not affect the product quality.
11.2 LEAK TEST:
PAGE No.: 9 of 17
Objective:
The objective of the test to determine the leakage in bottle.
Scope:
The Scope of this test limited to the Dry Powder Filling Area of Cephalosporin Block at Malik
Lifesciences Pvt. Ltd.
Test Instrument:
Leak Test Apparatus
PROCEDURE:
 The test shall be performing at the preset speed.
 The test shall be perform on 3 consecutive batches.
 Switch “ON” the machine & operate as per SOP.
 Set the Temperature at 90°C -100°C.
 Collect the 10 bottles continuous initial, middle and Final and each variability.
 Perform leak test at specified in BPR.
 Record the data in annexure-III.
11.3 ACCEPTANCE CRITERIA:

Leakage should not observed.
12.0 CHECKLIST OF ALL TESTS & CHECKS:
The following table lists the number of tests / samples to be carried out & comments on the sample
record sheet.
TESTS OR CHECKS EXECUTED [Y/N] COMMENT

CONVEYER SPEED TEST
LEAK TEST
PAGE No.: 10 of 17
13.0 REFERENCES:
The Principle Reference is the following:
 Validation Master Plan
 Schedule M: “Good Manufacturing Practices and Requirements of Premises, Plant and
Equipment for Pharmaceutical Products.”
 WHO Essential Drugs and Medicines Policy, QA of Pharmaceuticals, Vol-2: Good
Manufacturing Practices and Inspection.
The following references are used to give addition guidance:
 FDA/ISPE Baseline Pharmaceutical Engineering Guide-Volume 5: Commissioning and
Qualification Guide, First Edition / March 2001.
 Code of Federal Regulations (CFR), Title 21, Part 210, Current Good Manufacturing Practice
(cGMP) in Manufacturing, Processing, Packing, or Holding of Drugs, Beta. April 1, 1998.
 Code of Federal Regulations (CFR), Title 21, Part 211, Current Good Manufacturing Practice
(cGMP) for Finished Pharmaceuticals, April 1, 1998.
 EU Guide to Good Manufacturing Practice, Part 4, 1997.
 European Commission’s working party on control of medicines and inspections document,
Validation Master Plan, Design Qualification, Installation & Operational Qualification, Non Sterile
Process Validation, Cleaning Validation, October 1999.
 GMP Guide, Validation of Automated Systems in Pharmaceutical Manufacture, Version 4.0,
December 2001.
14.0 DOCUMENTS TO BE ATTACHED:

 Any Other Relevant Documents.
15.0 NON COMPLIANCE:
All the Non compliances of procedure, specifications, and sampling, analysis and documentation
activities shall be monitored & recorded.
PAGE No.: 11 of 17
16.0 DEVIATION FROM PRE-DEFINED SPECIFICATION, IF ANY:

 In case of any deviation observed during PQ, inform to Head QA for necessary action.
 Document the deviation detail in observed deviation section.
 The Head QA shall study the impact of deviation. If deviation is acceptable and it does not have
an impact on operation as well as on performance of the machine, prepare final conclusion.
17.0 CHANGE CONTROL, IF ANY:
 If any change control is required during PQ, inform to Head QA for necessary action.
 Document the details observed.
 The Head QA shall study the impact of change. If change is acceptable and it does not have an
impact on operation as well as on performance of the machine, prepare final conclusion.
PAGE No.: 12 of 17
18.0 ABBREVIATIONS:
Sr. : Senior
No. : Number
gm : gram
BSS : British Standard Sieve
BMR : Batch Manufacturing Record
WHO : World Health Organization
FDA : Food and Drug Administration
CFR : Code of Federal Regulations
GMP : Good Manufacturing Practices
QA : Quality Assurance
CQA : Corporate Quality Assurance
SOP : Standard Operating Procedure
RH : Relative Humidity
o
C : Degree Centigrade
mm : Millimeter
Amp. : Amper
DQ : Design Qualification
IQ : Installation Qualification
OQ : Operational Qualification
PQ : Performance Qualification
Pvt. : Private
Ltd. : Limited
IPR : Intellectual Property Rights
M.L.P.L. : Malik Lifesciences Private Limited
PAGE No.: 13 of 17
19.0 ANNEXURE:
S. Title
No.
1. Training Record
2. Result of Conveyer Speed Test
3. Result of Leak Test
PAGE No.: 14 of 17
Annexure-I
(Training Detail)
S. No. Name Department Sign. Duration Remarks
Trainer Name:
Date & Sign:
PAGE No.: 15 of 17
Annexure-II
(Result of Conveyer Speed Test)
Product Name: Batch No.:
Manufacturing date: Expiry Date:
At Minimum Speed (30 feet/min):
Date Interval Qty. Taken Leakage Rejected Pass Checked By Verified By

Initial
Middle
Final
At Standard Speed (40 feet/min):

Initial
Middle
Final
At Maximum Speed (50 feet/min):

Initial
Middle
Final
Checked By Verified By
Production Quality Assurance
Sign / Date Sign / Date
Inference:…………………………………………………………………………………………………..
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………
Reviewed By:__________________
Manager QA
Sign / Date
PAGE No.: 16 of 17
Annexure-II
(Result of Leak Test)
Product Name: Batch No.:
Manufacturing date: Expiry Date:
At Minimum Temperature (90°C):

Initial
Middle
Final
At Standard Temperature (95°C):

Initial
Middle
Final
At Maximum Temperature (100°C):

Initial
Middle
Final
Checked By Verified By
Production Quality Assurance
Sign / Date Sign / Date
Inference:…………………………………………………………………………………………………..
………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………
………
Reviewed By:__________________
Manager QA
Sign / Date
PAGE No.: 17 of 17

Performance Qualification Protocol FOR Induction Sealing Machine (Cephalosporin Block)

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MALIK LIFESCIENCES PERFORMANCE QUALIFICATION PROTOCOL No.

INDUCTION SEALING MACHINE

EQUIPMENT ID No. ML/CB/ICS-02

S. No. TITLE PAGE No.

5.0 Equipment Details 6

6.0 System Description 6

7.0 Reason For Qualification 6

8.0 Site of Study 6

9.0 Frequency of Qualification 6

1.0 PROTOCOL APPROVAL:

DESIGNATION NAME SIGNATURE DATE

DESIGNATION NAME SIGNATURE DATE

DESIGNATION NAME SIGNATURE DATE

DESIGNATION NAME SIGNATURE DATE

 Review of Performance Qualification report.

5.0 EQUIPMENT DETAILS:

Equipment Name Induction Sealing Machine

Supplier’s Name Electronic Device

Location of Installation Cephalosporin Block

6.0 SYSTEM DESCRIPTION:

7.0 REASON FOR QUALIFICATION:

8.0 SITE OF STUDY:

Cephalosporin Block, Malik Lifesciences Pvt. Ltd, Haridwar.

9.0 FREQUENCY OF QUALIFICATION:

10.0 PRE-QUALIFICATION REQUIREMENTS:

10.2 SYSTEM PRE-REQUISITES:

Verify that the DQ / IQ / OQ of

11.0 TESTS & CHECKS:

11.1 CONVEYER SPEED TEST:

11.2 LEAK TEST:

11.3 ACCEPTANCE CRITERIA:

TESTS OR CHECKS EXECUTED [Y/N] COMMENT

14.0 DOCUMENTS TO BE ATTACHED:

15.0 NON COMPLIANCE:

16.0 DEVIATION FROM PRE-DEFINED SPECIFICATION, IF ANY:

17.0 CHANGE CONTROL, IF ANY:

S. No. Name Department Sign. Duration Remarks

Date & Sign:

Product Name: Batch No.:

Manufacturing date: Expiry Date:

At Minimum Speed (30 feet/min):

Date Interval Qty. Taken Leakage Rejected Pass Checked By Verified By

At Standard Speed (40 feet/min):

Date Interval Qty. Taken Leakage Rejected Pass Checked By Verified By

At Maximum Speed (50 feet/min):

Date Interval Qty. Taken Leakage Rejected Pass Checked By Verified By

Product Name: Batch No.:

Manufacturing date: Expiry Date:

At Minimum Temperature (90°C):

Date Interval Qty. Taken Leakage Rejected Pass Checked By Verified By

At Standard Temperature (95°C):

Date Interval Qty. Taken Leakage Rejected Pass Checked By Verified By

At Maximum Temperature (100°C):

Date Interval Qty. Taken Leakage Rejected Pass Checked By Verified By

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